Kodiak 10.28$ (-80%)
- Kodiak Science wollte Eylea von Regeneron herausfordern
- nun kam alles anders
- KSI-301 zeigte keine ähnliche Verbesserung des Sehvermögens bei Patienten wie Eylea
- während die Studie zeigte, dass das Medikament sicher war, verbesserte es das Sehvermögen insgesamt nicht so effektiv wie Eylea
https://www.benzinga.com/general/biotech/22/02/...-are-plunging-today
Mk 530 Mio. $, bei rund 800 Mio. $ Cash (Ende Q3/21) und einem Cashburn von ~70 Mio. $ /pro Quartal. Watchlist
https://medcitynews.com/2022/02/...s-prospects-for-challenging-eylea/
Zahlen für Q4/21
- keine Umsätze
- Verlust 93 Mio. $
- Cash 732 Mio. $
- MK 457 Mio. $
- Announce top-line data for BEACON, Phase 3 pivotal study of KSI-301 in RVO, 3Q 2022
https://ir.kodiak.com/news-releases/...rth-quarter-and-full-year-2021
Für Q1/22 können vermutlich auch nochmal rund ~100 Mio. $ Cashburn abgezogen werden. Der nächste Katalysator kommt erst in Q3/22. Würde erstmal abwarten, wie der Markt die Q-Zahlen aufnimmt.
https://www.fool.com/investing/2022/03/05/...y-if-youre-a-contrarian/
The opening ceremony took place on May 17, 2022 following mechanical completion of the facility in March 2022
BASEL, Switzerland and PALO ALTO, Calif., May 19, 2022 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, and Lonza announced today the opening of a new, custom-built, bioconjugation facility within Lonza's Ibex® Dedicate manufacturing complex in Visp (CH).
The facility will play a key role in the scaled manufacturing of Kodiak's lead therapeutic candidate KSI-301 to support a potential global commercial launch. Once fully operational and if KSI-301 is approved for commercial use, the facility is expected to have the capacity to supply over 10 million dose equivalents of KSI-301 annually. The strong relationship between Kodiak and Lonza has led to a multi-year commercial collaboration that has created 12 full-time positions at Kodiak Sciences in Visp and 70 positions at Lonza.
Kodiak Sciences leverages its core technology, the Antibody Biopolymer Conjugate (ABC) PlatformTM, to develop next-generation, long-durability ophthalmic therapies. KSI-301 is the lead product candidate based on the ABC Platform, consisting of a custom-built antibody inhibiting Vascular Endothelial Growth Factor (VEGF), a potent cytokine known to contribute to the pathology of retinal vascular diseases, conjugated with a phosphorylcholine biopolymer. Existing clinical data has demonstrated the potential for extended dosing of up to six months in certain patients treated with KSI-301. KSI-301 is currently being studied in parallel Phase 3 trials for wet age-related macular degeneration ("wet AMD"), diabetic macular edema ("DME"), retina vein occlusion ("RVO"), and non-proliferative diabetic retinopathy ("NPDR"). If successful, Kodiak Sciences intends to include data from these trials in a Biologics License Application (BLA) with the U.S. FDA and potentially other global regulatory agencies. Lonza will support Kodiak in scaling up and securing supply chain as Kodiak progresses towards BLA readiness and potential commercial launch to meet growing market demand.
Victor Perlroth, MD, Chief Executive Officer, Kodiak Sciences Inc., commented: "The grand opening of Ursus, our dedicated bioconjugate facility, is an important milestone in our journey to develop medicines for patients in need worldwide. We are thankful to have our trusted partner Lonza, a global leader with the needed expertise, systems and production capacity, navigate the challenges of manufacturing and supplying KSI-301, our lead product candidate. We are also very appreciative of the long-standing support from the local community of Visp and the canton of Valais."
Pierre-Alain Ruffieux, Chief Executive Officer, Lonza, added: "It is a privilege to work alongside Kodiak to develop this world-class suite for ophthalmic technologies through our innovative Ibex® Dedicate offering. Our relationship with Kodiak has evolved over the last seven years, from the development of the antibody, to incorporating conjugation and now opening this dedicated suite. This journey reflects how our two businesses are able to work as one team towards a single purpose."
Christophe Darbellay, Conseiller d'Etat, Chef du Département de l'Economie et de la Formation du Canton du Valais, added: "The grand opening of Kodiak Sciences' manufacturing facility confirms and reinforces the position of Valais in life sciences. I would like to thank Kodiak Sciences for having chosen and trusted our canton and its capacities."
Lonza's leadership in bioconjugation, together with its experience in managing the complex supply chains under one quality system, will help Kodiak meet the precision standards required for ophthalmic intravitreal injected therapies. The new dedicated bioconjugation facility will allow for rapid product launch and provide flexible commercial manufacturing capacity that can scale to meet market needs. Lonza will also utilize its global network of facilities, including Nansha (CN) and Visp (CH) to produce Kodiak's biopolymer, and Portsmouth (U.S.) to produce Kodiak's monoclonal antibody.
About Lonza
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021.
Phase 3 Studie von KSI-301 (Netzhautvenenverschluss) erreicht den primären Endpunkt
https://ir.kodiak.com/news-releases/...topline-results-beacon-phase-3
Zahlen für Q3/22
- keine Umsätze
- Verlust 77 Mio. $
- Cash 537 Mio. $
- MK 278 Mio. $
"Wir setzen unser umfassendes zulassungsrelevantes klinisches Programm für Tarcocimab-Tedromer fort und bleiben auf Kurs, um im Laufe der nächsten Topline-Ergebnisse für alle laufenden Phase-3-Studien zu diabetischem Makulaödem, feuchter altersbedingter Makuladegeneration und nicht-proliferativer diabetischer Retinopathie in den nächsten 12 Monaten vorzulegen"
https://ir.kodiak.com/news-releases/...quarter-2022-financial-results
Hoher Cashburn, dafür kurz -bis mittelfristige Katalysatoren.
Zahlen für Q4/22
- keine Umsätze
- Verlust 70 Mio. $
- Cash 479 Mio. $
- MK 262 Mio. $
Expected Upcoming Events/Milestones
- Treatment of first subjects in Phase 1 study of KSI-501 in DME, 2Q2023
- GLEAM and GLIMMER, paired Phase 3 studies of tarcocimab in DME, 3Q2023 (expected July)
- DAYLIGHT, Phase 3 study of tarcocimab in wAMD, 3Q2023
- GLOW, Phase 3 study of tarcocimab in NPDR without DME, 3Q2023
https://ir.kodiak.com/news-releases/...rth-quarter-and-full-year-2022
Wenn man für Q1 & Q2 nochmal je 70 Mio. $ Verlust ansetzt, müsste der Cashbestand dann bei 340 Mio. $ liegen, immer noch höher als die momentane MK.
- Topline-Ergebnisse der Phase-3-Studien zu Tarcocimab-Tedromer bei neovaskulärer altersbedingter Makuladegeneration und diabetischem Makulaödem
- die Studien GLEAM und GLIMMER erreichten ihre primären Wirksamkeitsendpunkte nicht
https://ir.kodiak.com/news-releases/...ne-results-its-phase-3-studies
Zahlen für Q1/23
- kein Umsatz
- Verlust 71 Mio. $
- Cash 421 Mio. $
- MK 169 Mio. $
https://ir.kodiak.com/news-releases/...quarter-2023-financial-results
Laut Kodiak soll die Cashposition Ende Juli bei 379 Mio. $ gelegen haben.
Zahlen für Q2/23
- kein Umsatz
- Verlust 80 Mio. $
- Cash 379 Mio. $
- MK 142 Mio. $
https://ir.kodiak.com/news-releases/...quarter-2023-financial-results